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Management of Chronic Hepatitis C
Evidence Reports/Technology Assessments, No. 60
Investigators: Kelly A Gebo, MD, MPH, Mollie W Jenckes, MHSc, BSN, Geetanjali Chander, MD, Michael S Torbenson, MD, Khalil G Ghanem, MD, H Franklin Herlong, MD, Mark S Sulkowski, MD, Samer S El-Kamary, MD, Kirk A Harris, BA, Otto C Guedelhoefer, and Eric B Bass, MD, MPH.
Structured Abstract
Objectives:
Hepatitis C is the most common blood-borne infection in the United States and can lead to serious complications including cirrhosis and hepatocellular carcinoma (HCC). The objectives of this report are to summarize evidence on the following questions in the management of chronic hepatitis C: How well do results of liver biopsy predict outcomes of treatment for chronic hepatitis C? How well do biochemical blood tests and serologic measures of fibrosis predict the findings of liver biopsy in chronic hepatitis C? What is the efficacy and safety of current treatment options for chronic hepatitis C in treatment-naive patients and in selected subgroups? What are the long-term outcomes of current treatment options for chronic hepatitis C? What is the efficacy of using screening tests for HCC to improve outcomes in chronic hepatitis C? What are the sensitivity and specificity of tests used to screen for HCC in chronic hepatitis C?
Search strategy:
Eight electronic databases were searched for the period between January 1996 to March 2002. Additional articles were identified by searching for references in pertinent articles and current relevant journals and by querying technical experts.
Selection criteria:
Articles were eligible for review if they reported original human data from a study that was designed to address a key question and that used virologic, histologic, pathologic, or clinical outcome measures. Each question had additional eligibility criteria.
Data collection and analysis:
Paired reviewers assessed the quality of each eligible study and abstracted data. Data were assembled in evidence tables to facilitate synthesis.
Main results:
For the six questions investigated, the results are as follows: 1) studies were relatively consistent in suggesting that advanced fibrosis or cirrhosis on initial liver biopsy may be an independent predictor of a slightly decreased likelihood of having a sustained virological response to treatment; 2) studies were relatively consistent in showing that serum liver enzymes have modest value in predicting fibrosis on biopsy; the extracellular matrix tests, hyaluronic acid and laminin, may have value in predicting fibrosis, and panels of tests may have the greatest value in predicting fibrosis or cirrhosis; 3) studies of treatment-naive patients with chronic hepatitis C showed greater efficacy of pegylated (peg) interferon plus ribavirin when compared to standard interferon plus ribavirin or peginterferon alone, greater efficacy of peginterferon when compared to standard interferon, and no significant increase in efficacy with standard interferon plus amantadine when compared to interferon monotherapy; for nonresponders and relapsers, standard interferon plus ribavarin was more efficacious than interferon alone; little evidence existed on treatment efficacy in HIV-infected patients, renal patients, hemophiliacs, or intravenous drug users; 4) studies were mildly consistent in suggesting that interferon-based therapies decrease the risk of HCC and cirrhosis in complete responders; 5) one study suggested that HCC was detected earlier and was more often resectable in patients who had quarterly screening with serum alpha-fetoprotein (AFP) and ultrasound than in those who had usual care; 6) studies were relatively consistent in suggesting that a serum AFP greater than 10 ng/mL has a sensitivity of 75 to 80 percent and a specificity of about 95 percent in screening for HCC, and a serum AFP greater than 400 ng/mL has a specificity of nearly 100 percent for detection of HCC.
Conclusions:
The evidence suggests that liver biopsy may have some usefulness in predicting the efficacy of treatment in patients with chronic hepatitis C, and that biochemical blood tests and serologic tests have modest value in predicting the results of liver biopsy. The most efficacious treatment for chronic hepatitis C is peginterferon plus ribavirin; however few studies have examined treatment efficacy in injection drug users and those co-infected with HIV. Screening for HCC with AFP and ultrasound may improve outcomes, but studies are needed to identify the optimal screening strategy.
Contents
- Preface
- Summary
- 1. Introduction
- 2. Methodology
- 3. Results
- Literature Search and Abstract Review
- Article Review
- Q1b How well do the results of initial liver biopsy predict outcomes of treatment in patients with chronic hepatitis C, taking into consideration patient characteristics such as viral genotype?
- Q1e How well do biochemical blood tests and serological measures of fibrosis predict the findings of liver biopsy in patients with chronic hepatitis C?
- Q2a What is the efficacy and safety of current treatment options for chronic hepatitis C in treatment-naive patients, including peginterferon plus ribavirin, peginterferon alone, interferon plus ribavirin, and interferon plus amantadine?
- Q2c What is the efficacy and safety of current interferon-based treatment options (including interferon alone) for chronic hepatitis C in selected subgroups of patients, especially those defined by the following characteristics: age less than or equal to 18 years, HCV genotype, presence or absence of cirrhosis, minimal versus decompensated liver disease, concurrent hepatitis B or HIV infection, nonresponse to initial interferon-based therapy, and relapse after initial interferon-based therapy?
- Q2d What are the long-term clinical outcomes (greater than or equal to 5 years) of current treatment options for chronic hepatitis C?
- Q3a What is the efficacy of using screening tests for HCC to improve clinical outcomes in patients with chronic hepatitis C?
- Q3b What are the sensitivity, specificity, and predictive values of tests that could be used to screen for HCC (especially resectable carcinoma)?
- 4. Conclusions
- 5. Future Research
- Question 1b (Relation of Initial Liver Biopsy Findings to Outcomes of Treatment)
- Question 1e (Tests for Predicting Fibrosis on Liver Biopsy)
- Questions 2a/c (Treatment of Chronic Hepatitis C)
- Question 2d (Long-term Outcomes of Chronic Hepatitis C)
- Questions 3a and 3b (Screening for HCC)
- Overall Areas of Future Research
- Evidence Tables
- Appendixes
- Acronyms and Abbreviations
- Reference List
- Bibliography
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No: 290-97-0006. Prepared by: Johns Hopkins Evidence-based Practice Center.
Suggested citation:
Gebo K, Jenckes M, Chander G, et al. Management of Chronic Hepatitis C. Evidence Report/Technology Assessment No. 60 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No 290-97-0006). AHRQ Publication No. 02-E030. Rockville, MD: Agency for Healthcare Research and Quality. July 2002.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve the quality of health care services.
The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.
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2101 East Jefferson Street, Rockville, MD 20852. www
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- [Hepatocellular carcinoma--an increasing problem in the Western world].[MMW Fortschr Med. 2009][Hepatocellular carcinoma--an increasing problem in the Western world].Wiedermann KH. MMW Fortschr Med. 2009 Apr 9; 151(15):40-3.
- [Hepatocellular carcinoma associated with non-cirrhotic chronic hepatitis C].[Rev Esp Enferm Dig. 2007][Hepatocellular carcinoma associated with non-cirrhotic chronic hepatitis C].Lucero Pizones JA, Salman Monte Z, Jou Muñoz C, Novella Durán M, García Gutiérrez MJ. Rev Esp Enferm Dig. 2007 Jun; 99(6):364-5.
- Review [From viral hepatitis to hepatocellular carcinoma].[Nihon Naika Gakkai Zasshi. 2001]Review [From viral hepatitis to hepatocellular carcinoma].Okita K. Nihon Naika Gakkai Zasshi. 2001 Mar 10; 90(3):452-6.
- Review [Development of hepatocellular carcinoma from chronic hepatitis C].[Nihon Rinsho. 2011]Review [Development of hepatocellular carcinoma from chronic hepatitis C].Yoshida H. Nihon Rinsho. 2011 May; 69 Suppl 4:309-13.
- Management of Chronic Hepatitis CManagement of Chronic Hepatitis C
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